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The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabeprazole sodium | Drug | administered orally and once daily to patients randomized to receive either 10 mg or 20 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table. | 8 weeks from randomization and end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yufang Lu | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longmont Medical Research Network | Longmont | Colorado | 80501 | United States | ||
| Nova Southeastern University |
There was a screening period of up to 2 days before treatment assignment
This study was recruited at 25 centers in the US during the period of 18-Aug-2005 and 1-May-2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rabeprazole 10 mg | once daily for 8 weeks |
| FG001 | Rabeprazole 20 mg | once daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fort Lauderdale |
| Florida |
| 33328 |
| United States |
| Babies and Beyond Peds | New Port Richey | Florida | 34652 | United States |
| Dr. Patricia Barrington, Dr. B. Abraham, PC | Snellville | Georgia | 30039 | United States |
| Multi-specialty Clinical Research | Hoffman Estates | Illinois | 60194 | United States |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | United States |
| Professional Clinical Research | Cadillac | Michigan | 49601 | United States |
| Community Pediatric Associates | Kalamazoo | Michigan | 49008 | United States |
| The Center for Human Nutrition | Omaha | Nebraska | 68105 | United States |
| Children's Hospital of Buffalo - Digestive Disease And Nutrition Center | Buffalo | New York | 14222 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Pediatric Associates of Mount Carmel, Inc. | Cincinnati | Ohio | 45245 | United States |
| Pediatric Associates of Mt. Carmel | Cincinnati | Ohio | 45245 | United States |
| University of Pediatrics | Mason | Ohio | 45040 | United States |
| Center for Children's Digestive Health | Youngstown | Ohio | 44514 | United States |
| Pharmacotherapy Research Associates | Zanesville | Ohio | 43701 | United States |
| Biomedical Research Associates | Shippensburg | Pennsylvania | 17257 | United States |
| DeGarmo Institute of Medicine Research | Greer | South Carolina | 29651 | United States |
| Focus Research Group | Hendersonville | Tennessee | 37075 | United States |
| ProMed Healthcare | Johnson City | Tennessee | 37601 | United States |
| NE Ohio University College of Medicine | Lebanon | Tennessee | 37087 | United States |
| Southwest Children's Research Associates | San Antonio | Texas | 78229 | United States |
| Alpine Medical Group | Salt Lake City | Utah | 84102 | United States |
| Rockwood Clinic North | Spokane | Washington | 99202 | United States |
| Marshall University | Huntington | West Virginia | 25701 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rabeprazole 10 mg | once daily for 8 weeks |
| BG001 | Rabeprazole 20 mg | once daily for 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table. | Safety population (all patients who received at least one dose of study treatment) was the primary analysis population. | Posted | Number | Participants | 8 weeks from randomization and end of treatment |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rabeprazole 10 mg | once daily for 8 weeks | 0 | 41 | ||||
| EG001 | Rabeprazole 20 mg | once daily for 8 weeks | 1 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mood swings | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upper andominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Otitis media | Infections and infestations | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yufang Lu, MD, PhD, Study Director | Eisai Medical Research Inc. | 201-403-2500 |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Male |
|
| Black or African American |
|
| White |
|
| Hispanic |
|
| Other |
|
| Upper abdominal pain |
|
| Chest pain |
|
| Upper respiratory tract infection |
|
| Bronchitis |
|
| Pharyngitis |
|
| Sinusitis |
|
| Nasopharyngitis |
|
| Otitis media |
|
| Headache |
|
| Pharyngolaryngeal pain |
|
| Cough |
|
| Nasal congestion |
|
| Total # subjects reporting AEs |
|